- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01967108
Post Extubation Chest Physiotherapy in ICU
May 6, 2015 updated by: Rambam Health Care Campus
The Effect of Post Extubation Chest Physiotherapy on Respiratory Complications and Weaning Failure in Critically Ill Patients
The purpose of this study is to examine the efficacy of chest physiotheray treatment in preventing pulmonary complications and weaning faliure, in extubated critically ill patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Intensive Care Unit, Rambam Health Care Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:ICU patients, over 18 years' old, mechanical ventilated over 24 hours, candidates for extubation -
Exclusion Criteria: Mental conditions, retardation, dementia, pregnancy, re-intubated patients
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chest physiotherapy
chest physiotherapy in patient's bed, including deep breathing, directed cough, arm movment and more.
|
chest physiotherapy, up to one hour from extubation, in ICU patients
|
No Intervention: control group
This patients will not recive chest physiotherapy after extubation, unless developing respiratory deterioration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
re-intubation
Time Frame: 48 hours
|
re-intubation up to 48 hours post extubation will be considered a weaning failure
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
oxygen saturation decrease
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Enbar Foox, B.PT, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
October 17, 2013
First Submitted That Met QC Criteria
October 17, 2013
First Posted (Estimate)
October 22, 2013
Study Record Updates
Last Update Posted (Estimate)
May 7, 2015
Last Update Submitted That Met QC Criteria
May 6, 2015
Last Verified
February 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 0346-13-RMB CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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